Regulation (EC) No. 1223/2009 stands as the cornerstone of cosmetic legislation in the European Union (EU). In this article, we explore the key aspects of this legal instrument.
Regulation (EC) No. 1223/2009 applies to any cosmetic product made available on the EU market. It defines “cosmetic product” as «any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours» and comprehensively harmonises the rules in the EU in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.
In order to establish clear responsibilities, the Regulation requires each cosmetic product to be linked to a Responsible Person established within the EU that must ensure compliance with the relevant obligations set out in the Regulation.
Compliance with Good Manufacturing Practice (GMP) is an obligation under Article 8. Manufacturers must adhere to relevant harmonised GMP standards to ensure the quality and safety of cosmetic products during production.
The Regulation establishes a list of prohibited (Annex II) and restricted (Annex III) substances in cosmetic products to safeguard consumer health. In addition, it lists the permitted colourants (Annex IV), preservatives (Annex V) and UV filters (Annex VI).
Clear and accurate labelling is also crucial under Regulation (EC) No. 1223/2009 and must include essential information such as the list of ingredients and the contact information of the Responsible Person.
Prior to placing a cosmetic product on the market, the Responsible Person must ensure that the cosmetic product has undergone a safety assessment and that a Cosmetic Product Safety Report (CPSR) is set up.
The CPSR is an integral part of the Product Information File (PIF), also mandatory for each cosmetic product placed on the market, under Article 11. The PIF must be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
Prior to placing the cosmetic product on the market, the Responsible Person must notify it through the Cosmetic Product Notification Portal (CPNP).
The Regulation emphasizes the importance of market surveillance, empowering competent authorities to monitor and take corrective actions to remove unsafe products from the market.